Long-term data show inhibition of structural damage and sustained improvement in functional status and quality of life

SAN DIEGO, CALIF., NOVEMBER 13, 2005 – New data, including two-year treatment duration, show a significantly higher proportion of patients with active psoriatic arthritis receiving REMICADE® (infliximab) achieved and sustained a high degree of clinical improvement in arthritis, as assessed using the rheumatoid arthritis (RA) definition for "major clinical response," compared with patients receiving placebo. "Major clinical response" is defined as maintenance of a 70 percent improvement in the American College of Rheumatology score (ACR 70) for six continuous months. REMICADE maintenance therapy also resulted in the inhibition of structural damage and significant improvements in functional status and quality of life as maintained over the course of one year. Investigators will present these long-term Phase 2 and 3 study findings this week at the American College of Rheumatology 2005 Annual Scientific Meeting. REMICADE is currently indicated for reducing signs and symptoms of active arthritis in patients with psoriatic arthritis.

"Previous study findings have shown the rapidity and therapeutic intensity of infliximab in treating the joint and skin manifestations associated with active psoriatic arthritis," said Arthur Kavanaugh, MD, Director, Center for Innovative Therapy, Division of Rheumatology, Allergy and Immunology, University of California, San Diego, and lead study investigator. "These data demonstrate the rapid efficacy of infliximab can be sustained over time, especially as it relates to the arthritic component of this complex disease."

An analysis of two double-blind, placebo-controlled trials, Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT) and Induction and Maintenance Psoriatic Arthritis Clinical Trial 2 (IMPACT 2), followed patients for two years (98 weeks) and one year (54 weeks), respectively, and confirmed a significant, high degree of clinical responses in the arthritic component of the disease. Placebo patients in both studies crossed over to active treatment by week 16 in IMPACT and week 24 in IMPACT 2. In IMPACT, 35 percent of all randomized patients (including patients originally randomized to REMICADE and placebo) entering the second year (27 out of 78) achieved an ACR 70 improvement at week 98. In IMPACT 2, 20 percent of REMICADE randomized patients (20 out of 100) achieved this high degree of improvement at week 54.

In both IMPACT and IMPACT 2, "major clinical response," a post hoc analysis, was defined for REMICADE randomized patients as maintenance of a 70 percent improvement in ACR 70 for six continuous months anytime during the study. Placebo patients were conservatively counted as achieving "major clinical response" if they had achieved ACR 70 improvement at the last visit before receiving REMICADE. In IMPACT, 31 percent of patients randomized to REMICADE (16 out of 52) achieved a "major clinical response" versus zero percent of patients receiving placebo (P < 0.001).

In IMPACT 2, 12 percent of REMICADE randomized patients (12 out of 99) achieved a "major clinical response" versus two percent of patients receiving placebo (P = 0.006). "Major clinical response" identifies a high degree of sustained clinical improvement in arthritis but does not currently account for the skin disease associated with psoriatic arthritis.

According to one-year results from the IMPACT 2 trial, radiographic analyses showed treatment with REMICADE resulted in significantly less progression of structural damage, compared with patients receiving placebo, as measured by the change in baseline in van der Heijde-Sharp (vdH-S) score in which higher scores indicate greater structural damage, while lower scores indicate less structural damage. At as early as 24 weeks of treatment, REMICADE patients experienced a mean change (+/- standard deviation) in vdH-S score of -0.70 (+/- 2.53) from baseline, compared with an average change of 0.82 (+/- 2.62) in the placebo group (P < 0.001). At week 54, patients who received a full 54-week regimen of REMICADE experienced a mean change of -0.94 (+/- 3.40) from baseline, compared with an average change of 0.53 (+/- 2.60) in patients who crossed over from placebo to REMICADE (P = 0.001). REMICADE and crossover patients experienced a total improvement of -0.24 (+/- 2.45) and -0.29 (1.98), respectively, from week 24 to 54.

"These radiographic findings are significant in the treatment of active psoriatic arthritis, which like rheumatoid arthritis, is a progressive immune-mediated inflammatory disease," said Desiree van der Heijde, MD, PhD, Professor of Rheumatology, University of Maastricht in the Netherlands and lead study investigator. "The inhibition of joint destruction is critical in the management of disease and these radiographic data show the long-term, sustained effect of REMICADE therapy in the course of the disease."

REMICADE Therapy Results In Sustained Improvement In Functional Status And Quality Of Life In Patients With Psoriatic Arthritis: 1-Year Results From The IMPACT 2 Study

One-year data presented from IMPACT 2 showed REMICADE-treated patients experienced sustained improvement in health-related quality of life, as assessed by the Short Form 36 (SF-36), a questionnaire that assesses impact in the areas of physical function, pain, social function and general health perceptions, in which higher scores indicate better well-being. At week 14, REMICADE patients showed significant improvement in the physical component summary (PCS) and the mental component summary (MCS) of the SF-36 compared with patients receiving placebo. Additionally, REMICADE-treated patients showed a median increase of 8.7 in PCS score, compared with a 1.0 increase in placebo-treated patients (P < 0.001). Patients receiving REMICADE also experienced a median improvement of 2.1 in MCS score, compared with 0.5 in placebo-treated patients (P < 0.001). At week 54, median improvement from baseline in PCS and MCS in the REMICADE group was 7.4 and 2.8, respectively, and the median improvement in the placebo/REMICADE group, the group of patients initially receiving placebo and crossed over to REMICADE by week 24, was 10.2 and 1.9, respectively. At week 14, the median improvement from baseline in Health Assessment Questionnaire (HAQ) was 43 percent in the REMICADE group, compared with no change in the placebo group (P < 0.001). This improvement was maintained at week 54, with a 50 percent median improvement from baseline in the group randomized to REMICADE, indicating significantly improved physical function.

Source: Eurekalert & others

Last reviewed:
By John M. Grohol, Psy.D. on
21 Feb 2009
Published on PsychCentral.com. All rights reserved.

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